Heart valve disorders rank second in all cardiovascular diseases that contribute to mortality in the western and eastern worlds, and impose significant financial burden on healthcare systems. Currently, patients receive either medical treatment or surgical repair or replacement using open heart surgery. Medical treatment is only a medical management option that reduces the symptoms in these patients. However, medical treatment typically only delays the need for more invasive procedure to correct the actual heart valve lesion. Most patients require some invasive procedure to correct the heart valve at some point in their life. In patients who receive surgery, traditional methods of surgery use either mechanical or bio-prosthetic replacement valves in place of native diseased valves, or the native diseased valve is repaired or corrected by manipulating the native valve tissue.
Valve replacement, however, has its drawbacks and has been losing traction as the standard of care. Valve replacement requires lifelong anti-coagulation therapy with mechanical heart valves, and has less than 10 years of durability with the use of bio-prosthetic heart valves.
Valve repair, on the other hand, is becoming more popular as the standard of care. Up to 250,000 valve repair procedures are performed each year in the United States alone. However, the durability of such repairs has been very sub-optimal with persistent or recurrent valve regurgitation occurring in up to 64% of the patients. Valve repair procedures typically fail because of the inflexibility of current valve repair devices, specifically, the inability of the procedure to address different valve defects on a patient specific basis using currently available commercial valve repair devices. Also, the procedure to implant current devices requires arresting the heart, assessing the appropriate device shape and size on a flaccid (non-beating) heart, closing the heart and chest via incisions, and then recovering the patient from cardiopulmonary bypass and anesthesia to assess if the valve repair was successful. Patients often have persistent or recurrent valve leakage when the heart resumes beating, even though complete elimination of regurgitation at the time of the valve surgery on the flaccid heart may have been observed. Thus, such patients present with regurgitation after valve repair surgery and often do not receive any additional care because a second surgery would increase the risk of mortality.
There are valve repair devices and methods that are designed to treat regurgitation. See, e.g., U.S. Pat. No. 8,092,525 issued Jan. 10, 2012 (Eliasen et al.); U.S. patent application Ser. No. 11/258,828 filed Oct. 26, 2005 (Eliasen et al.); U.S. Pat. No. 8,070,805 issued Dec. 6, 2011 (Vidlund et al.); U.S. Pat. No. 8,187,299 issued May 29, 2012 (Goldfarb et al.); U.S. patent application Ser. No. 12/858,935 filed Apr. 18, 2010 (Spence); U.S. patent application Ser. No. 12/626,272 filed Nov. 25, 2009 (Subramanian); and U.S. patent application Ser. No. 12/761,225 filed Apr. 15, 2010 (Zakay et al.). However, these devices are generally not structured to be adjusted and adapted to different valve defects on a patient specific basis.
Thus, there is a need for valve repair devices and methods that address the patient variability in heart valve structure and function. Specifically, there is a need for beating heart adjustable devices that conform to the desired shape in individual patients at the time of surgery, or acutely after surgery or several years after surgery.